Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

Obesity Clinical Trial

— CIBuS  

Official title:

Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990947
• Other study ID #: 2020-1594
• Status: Recruiting
• Start date: April 7, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2021
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: Female
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• Woman

• Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)

• Patients must be able to adhere to the study visit schedule

• Independently mobile

• Patients must be able to give informed consent (IC) prior to any study procedures

• Surgical (1) and non-surgical (2) groups:

1. Eligible for bariatric surgery (BMI > 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)

2. Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program

Exclusion Criteria:

• Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as:

Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal

• Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.

• Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)

• Pregnancy or lactation, or planning to get pregnant during the study period

• Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)

• Active and significant psychiatric illness including substance misuse

• Significant cognitive or communication issues

• Medications with documented effect on food intake or food preference

• Participating in another scientific study at the same time, if

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Lifestyle
• Obesity

Intervention

Other:
• lifestyle / RYGB
No intervention, just 2 different groups will be included

Locations

Country	Name	City	State
Netherlands	Yonta van der Burgh	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in caloric intake	kcal consumed	Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle
Secondary	Weight / BMI	weight and height measurements	baseline, 4weeks, 3 months, 6 months, 12 months
Secondary	Drinking microstructure over time	Measured with the drinkometer	baseline, 4weeks, 3 months, 6 months, 12 months
Secondary	Change in self-reported hunger, thirst, fullness, preference	VAS scale 0-100	baseline, 4weeks, 3 months, 6 months, 12 months